Law Commons^™

Renewing Faith In Antitrust: Unveiling The Hidden Network Behind Pharmaceutical Product Hopping, Victoria Field

Fordham Journal of Corporate & Financial Law

Patents grant time-limited market exclusivity to drug manufacturers, meaning that other companies are prohibited from copying and selling the patented pharmaceutical. This allows manufacturers to lawfully charge monopoly prices. Generic competition starts at the expiration of the patent. To maintain coveted monopoly power, manufacturers often release an alternative formulation of the drug with a fresh patent that enjoys continued market exclusivity. Manufacturers who can convert their consumer base to the new formulation can continue charging peak prices. This process, called “product hopping,” has been the target of significant antitrust inquiry, with mixed results.

A product hop may be the result …

Access To Medicines And Pharmaceutical Patents: Fulfilling The Promise Of Trips Article 31bis, Ezinne Mirian Igbokwe, Andrea Tosato

Fordham Law Review

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has long stood accused of reducing access to medicines for the poorest and most vulnerable nations. Enacted in 1994 as one of the founding pillars of the World Trade Organization, TRIPS has enabled pharmaceutical companies to enforce their patent rights in almost every country, precluding cheaper generics from being distributed, save for very limited exceptions.

But in 2001, TRIPS was amended expressly to address this issue, allowing countries with limited resources to lodge a formal request to obtain patented medicines at a sustainable cost. Generics manufacturers worldwide can answer this …

Interpleader As A Vehicle For Challenging The Constitutionality Of Private Citizen Action Statutes, Delia Parker

Fordham Law Review

The rise of vigilante-esque statutes creates obstacles for litigants seeking to challenge a statute’s constitutionality. State legislatures in Texas and California enacted laws regulating constitutionally protected activity (abortion and firearm possession, respectively) through statutes enforced solely by private actors. The state legislatures cleverly crafted Texas S.B. 8, as well as other copycat statutes, as bounty hunter statutes to block litigants’ usual path to pre-enforcement adjudication—filing a claim against the state to enjoin its actors from enforcing the improper provisions.

The Texas and California state legislatures attempted to forbid constitutionally protected conduct by granting enforcement power to an infinite number of …

Medical Harm Without Negligence, Valerie Gutmann Koch

Fordham Law Review

In December 2019, seven women from one family underwent highly invasive surgeries based on genetic test results that indicated that each were at significant risk of developing cancer by age seventy. Subsequently, after procedures that (among other things) permanently scarred and disfigured their bodies and ended their chances of having biological children, they learned that their particular mutation was not, in fact, pathogenic.

This Article focuses on a previously under-recognized problem: what happens when a patient’s previously classified pathogenic variant is downgraded to uncertain (or even benign) status? Intuitively, it might seem that the genetic testing company, the surgeons, or …

Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu

Fordham Law Review

The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …

Debunking The Standardized Nature Of Insurance Policies, Elizabeth Sousa

Fordham Journal of Corporate & Financial Law

This article discredits the conventional view of insurance policies as standardized contracts that do not vary across insurance companies and policyholders. Contrary to this view, there are wide variations in policy language in both the admitted and non-admitted insurance markets. These deviations reduce the perceived benefit of insurance policies as standardized contracts intended to promote predictability and lower transaction costs for policyholders by focusing only on the most salient terms. Nowhere is this deviation more apparent than with Commercial General Liability (CGL) policies defendants are turning to in the current opioid litigation.

The opioid epidemic has been plaguing the United …

Negligent Disruption Of Genetic Planning: Carving Out A New Tort Theory To Address Novel Questions Of Liability In An Era Of Reproductive Innovation, Tracey Tomlinson

Fordham Law Review Online

This Essay will address current concerns pertaining to ART-related negligence, and ultimately recommends the adoption of a new tort— negligent disruption of genetic planning (NDGP). This tort would enable plaintiffs to recover damages when an ART clinic’s negligent actions thwart reproductive planning, while simultaneously balancing the serious moral and ethical questions that arise in these situations. This argument proceeds in three Parts. Part I discusses the technological evolution of ART and gives examples of ART-related negligence cases that have occurred in the United States. Part II lays out the current U.S. tort remedies relied on by plaintiffs in these situations, …

The "Uncontroversial" Controversy In Compelled Commercial Disclosures, Lauren Fowler

Fordham Law Review

Federal and state administrative agencies increasingly advance public health goals through the use of mandatory disclosures, like warning labels on cigarettes, that are intended to both inform and influence consumer decisions. However, the standard for determining whether these requirements violate a commercial speaker’s First Amendment rights is unsettled. In Zauderer v. Office of Disciplinary Counsel, the U.S. Supreme Court adopted a test that defers to the government’s determination that the compelled disclosure of “factual and uncontroversial information” is justified. Since Zauderer was decided, lower courts have disagreed about the meaning of “uncontroversial.” A recent Supreme Court case, National Institute …

Dirty Little Secrets: Fracking Fluids, Dubious Trade Secrets, Confidential Contamination, And The Public Health Information Vacuum, Elliot Fink

Fordham Intellectual Property, Media and Entertainment Law Journal

While the carbon energy industry has frequently claimed that hydraulic fracturing processes and ingredients are proprietary and protected by trade secret laws, their large scale and volume nationwide and the well-documented dangers that they pose to public health have brought fracking under scrutiny. When individuals have been adversely impacted in their own backyards, weak federal and state laws and regulation have generally left these impacted citizens with little to no recourse and part of this problem stems from questionable uses of privacy law, specifically dubious claims of trade secrecy. Focusing specifically on Pennsylvania as a model of insufficient state regulation …

Rape Messaging, Alena Allen

Fordham Law Review

When feminists began advocating for rape reform in the 1970s, the rape message was clear: rape was not a crime to be taken seriously because women lie. After decades of criminal law reform, the legal requirement that a woman vigorously resist a man’s sexual advances to prove that she was raped has largely disappeared from the statute books, and, in theory, rape shield laws make a woman’s prior sexual history irrelevant. Yet, despite what the law dictates, rape law reforms have not had a “trickle-down” effect, where changes in law lead to changes in attitude. Women are still believed to …

Confronting The Ghost: Legal Strategies To Oust Medical Ghostwriters, Deanna Minasi

Fordham Law Review

Articles published in medical journals contribute significantly to public health by disseminating medical information to physicians, thereby influencing prescribing practices. However, the information guiding treatment decisions becomes distorted by selective publishing and medical ghostwriting, which negatively affects overall patient care. Although there is general consensus in the medical community that these practices of publication bias represent a moral failing, the issue is rarely framed as a wrong that necessitates legal consequences. This Note takes the stance that medical ghostwriting constitutes an act prohibited under the Racketeer Influenced and Corrupt Organizations Act (RICO) and argues that physicians fraudulently named as authors …

Leaders And Laggards: Tackling State Legislative Responses To The Youth Sports Concussion Epidemic, Chris Lau

Fordham Law Review

In 2009, state legislatures began to enact concussion safety laws to protect youth athletes suffering from traumatic brain injuries sustained during the course of play. By 2014, all fifty states and the District of Columbia had enacted some form of youth sports concussion legislation. Yet these statutes vary widely across states in terms of the protections offered to youth athletes. This Note provides an analysis of state legislation by classifying all fifty-one statutes among distinct tiers ranging from least to most protective.

The Contours Of The Parallel Claim Exception: The Supreme Court's Opportunity To Define The Ill-Defined, Jarret Sena

Fordham Urban Law Journal

No abstract provided.

Local Health Agencies, The Bloomberg Soda Rule, And The Ghost Of Woodrow Wilson, Paul A. Diller

Fordham Urban Law Journal

No abstract provided.

Health Reform And Correctional Health Care: How The Affordable Care Act Can Improve The Health Of Ex-Offenders And Their Communities, Joel B. Teitelbaum, Laura G. Hoffman

Fordham Urban Law Journal

No abstract provided.

With Liberty And Access For Some: The Aca’S Disconnect For Women’S Health, Nicole Huberfeld

Fordham Urban Law Journal

No abstract provided.

Healthy Reform, Healthy Cities: Using Law And Policy To Reduce Obesity Rates In Underserved Communities, Christine Fry, Sara Zimmerman, Manel Kappagoda

Fordham Urban Law Journal

No abstract provided.

Who’S Smiling Now?: Disparities In American Dental Health, Janet L. Dolgin

Fordham Urban Law Journal

No abstract provided.

Fair Warning?: The First Amendment, Compelled Commercial Disclosures, And Cigarette Warning Labels, Timothy J. Straub

Fordham Urban Law Journal

No abstract provided.

"It Takes A Lot To Get Into Bellevue": A Pro-Rights Critique Of New York's Involuntary Commitment Law, Zachary Groendyk

Fordham Urban Law Journal

No abstract provided.

Administrative Oversight Of State Medicaid Payment Policies:Giving Teeth To The Equal Access Provision, Julia Bienstock

Fordham Urban Law Journal

No abstract provided.

Fixing Medicaid To "Fix Society": Extending Medicaid Coverage Of Gender-Affirming Healthcare To Transgender Youth, Henry Parr

Fordham Urban Law Journal

No abstract provided.

History, Governmental Structure, And Politics: Defining The Scope Of Local Board Of Health Power, Pekham Pal

Fordham Law Review

Local boards of health often issue regulations that have broad effects that surpass the borders of the city or county to which they apply. Promulgation of such rules by board of health members appointed by the executive branch implicates separation of powers concerns; because such regulations may so extensively burden a locality’s citizens, it may be more appropriate for elected officials to adopt these regulations. Indeed, local businesses or other interested parties often bring suit challenging local board of health actions. Courts apply different analytical methodologies to review these challenges, which often leads to incongruent local health agency discretion for …

Newfound Religion: Mothers, God, And Infanticide, Susan Ayres

Fordham Urban Law Journal

This essay focuses on cultural constructions of infanticide and psychosis, especially cases in which the mother heard delusional commands to kill her children. Part I examines the background of the Yates, Laney, and Diaz cases. Part II explores whether these mothers can be seen paradoxically as feminist subjects of empowerment rather than as victims. This essay argues that psychotic mothers have been disempowered and silences, so their acts cannot be seen as subversive feminist gestures. Part III, however, argues that the legal trials of Laney and Diaz demonstrate a possible subversion through trial strategy. These two trials more fully told …

Hungry, Hungry Hippa: When Privacy Regulations Go Too Far, Meredith Kapushion

Fordham Urban Law Journal

This Comment explores the constructs and consequences of the Health Insurance Portability and Accountability Act of 1966 (“HIPAA”). HIPPA imposes considerable regulatory burdens on health care organizations in the hope that strict administration and control of information will prevent both real and perceived injuries from unauthorized and unwanted scrutiny of personal health data. In outlining the nature of HIPPA, the author presents what in her view are the Act’s shortcomings – HIPPA’s high costs, questionable benefits, and numerous economic, legal, and administrative consequences. As a result, the author presents alternatives to HIPPA that are less intrusive but still address the …

The Impact Of 9/11 And Its Aftermath On Substance Use And Psychological Functioning: An Overview, Patrick B. Johnson, Linda Richter

Fordham Urban Law Journal

This Essay provides a brief summary and evaluation of findings on the mental health and substance abuse consequences of the events of 9/11 throughout the nation and in United States' cities. It also presents new data obtained from clients who entered substance abuse treatment in New York and other cities either before 9/11 or during a six-month period following the events. This Essay discusses how best to interpret these varying research findings. It concludes that crisis produces many responses and most people just coped with 9/11 in their individual ways.

The Impact Of Managed Care Payer Contracts On The Subspecialty Medical Provider: Policy Implications That Impact On The Care Of Disabled Children, Dr. Stephanie Rifkinson-Mann

Fordham Urban Law Journal

This Note explores the impact of current managed care contractual practices on the subspecialty provider's ability to deliver health care to chronically ill and disabled children. In doing so, it delves into the historical events giving rise to the development of health care reform. It then reviews various physician agreements with several managed care organizations ("MCOs") to demonstrate how contract conditions affect compensation for pediatric neurosurgical services. This Note then details the impact of managed care on the management of the chronic health problems of such children and proposes alternative solutions for affordable health care delivery systems for poor, medically …

Hiv Name Reporting And Partner Notification In New York State, Sonia Bhatnager

Fordham Urban Law Journal

This Article focuses on a 1998 New York law that required physicians and other health officials to report individuals who test positive for HIV, AIDS, or other HIV-related illnesses to the municipal health commissioner. As New York has the highest rate of reported AIDS cases, the Article notes that the state's decision to enact this law could have significant influence on other states. It begins by describing the partner notification system laws in the United States, and then presents arguments for and against partner notification. The Article ultimately argues for a modified version of the New York law. This refined …

Community-Based Health Care: A Legal And Policy Analysis , Lewis D. Solomon, Tricia Asaro

Fordham Urban Law Journal

While Washington has been unable to lead the way in significant health care reform, the health care system has begun to transform itself in terms of curbing skyrocketing health care costs, dealing with the more than forty million Americans who lack health care coverage, and the problems plaguing the Medicare and Medicaid systems. The search has begun for a health care model that ensures quality care to a wide population in a cost-efficient manner. This article explores how the U.S. Health care system currently functions, examines several innovative models, and suggests ways in which a decentralized, community-based approach to health …

The "Baby Aids" Bill, Nettie Mayersohn

Fordham Urban Law Journal

Assemblywoman Mayersohn first explains the reasons behind her support for the so-called “Baby AIDS” bill; namely, that over one thousand babies in New York State tested positive for AIDS or HIV antibodies every year but medical professions were not allowed to reveal the results to anyone, including the mother. After the introduction of the bill, the author details how she received criticism and opposition from activist organizations that she had previously supported. In conclusion, the “Baby AIDS” bill is a success because it no longer treated infected infants as some sort of statistical tool and ensures the infants receive the …